GASTRORETENTIVE DUODENAL PILL

• US 20100286660A1
• Filed: 05/07/2009
• Published: 11/11/2010
• Est. Priority Date: 05/07/2009
• Status: Active Grant

• Current Assignee: Rainbow Medical Ltd.
• Original Assignee: Rainbow Medical Ltd.
• Inventors: GROSS, Yossi
• Granted Patent: US 8,414,559 B2
• Time in Patent Office: Days
• US Class Current: 604/516
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus is provided that includes a swallowable medical treatment device, which is configured to initially assume a contracted state having a volume of less than 4 cm3. The device includes a gastric anchor, which initially assumes a contracted size, and which is configured to, upon coming in contact with a liquid, expand sufficiently to prevent passage of the anchor through a round opening having a diameter of between 1 cm and 3 cm. The device also includes a duodenal unit, which is configured to pass through the opening, and which is coupled to the gastric anchor such that the duodenal unit is held between 1 cm and 20 cm from the gastric anchor. Other embodiments are also described.

Claims

1-14. -14. (canceled)

15. Apparatus comprising a swallowable medical treatment device, which is configured to initially assume a contracted state having a volume of less than 4 cm3, which comprises:

a gastric anchor, which comprises a flexible sheet which initially is rolled to assume a contracted size, which is configured to, upon coming in contact with a liquid, unroll to assume an expanded size that is sufficient to prevent passage of the anchor through a round opening having a diameter of between 1 cm and 3 cm, and which is shaped so as to define a hole therethrough having a radius of at least 0.4 cm; and

a medical treatment component, which is coupled to the gastric anchor.

16. The apparatus according to claim 15, wherein the treatment component comprises a drug.

17. The apparatus according to claim 15, wherein the treatment component comprises an electrical stimulator.

19. The apparatus according to claim 15,

wherein the opening is a pylorus of a subject,

wherein the liquid is stomach contents of the subject,

wherein the gastric anchor is configured to, upon coming in contact with the stomach contents, unroll to assume the expanded size that is sufficient to prevent passage of the anchor through the pylorus, and

wherein the hole is sized to allow chyme to pass to the pylorus.

36. The apparatus according to claim 17, wherein the electrical stimulator is configured to apply electrical stimulation, and to configure the stimulation to generate peristalsis.

37. The apparatus according to claim 17, wherein the electrical stimulator is configured to apply electrical stimulation at between 5 and 7 mA, and at a frequency of between 5 and 40 Hz.

38. The apparatus according to claim 15, wherein the medical treatment device further comprises one or more dissolvable elements, which initially hold the sheet rolled.

39. The apparatus according to claim 38, wherein the one or more dissolvable elements comprise one or more dissolvable rings, which are initially placed around the rolled sheet.

40. The apparatus according to claim 38, wherein the one or more dissolvable elements comprise a dissolvable glue that initially binds an outermost edge of the sheet to a more inner portion of the sheet.

41. The apparatus according to claim 38, wherein the one or more dissolvable elements are selected from the group consisting of:

a dissolvable capsule, and a dissolvable coating.

42. The apparatus according to claim 15, wherein the sheet, when unrolled, has a length of between 20 and 40 mm, and a width of between 10 and 30 mm.

18. (canceled)

20-26. -26. (canceled)

27. A method comprising:

receiving, by a subject, a swallowable treatment device in an initially contracted state, which includes (i) a gastric anchor, which includes a flexible sheet which initially is rolled to assume a contracted size, and which is shaped so as to define an hole therethrough having a radius of at least 0.4 cm, and (ii) a treatment component coupled to the gastric anchor; and

swallowing the treatment device by the subject, so that the anchor, upon coming in contact with stomach contents of the subject, unrolls sufficiently to prevent passage of the anchor through a pylorus of the subject, and to allow chyme to pass through the hole to the pylorus.

28. The method according to claim 27, wherein the treatment component includes a drug, and wherein receiving comprises receiving the treatment device including the gastric anchor and the drug.

29. The method according to claim 27, wherein the treatment component includes a gastric electrical stimulator, and wherein receiving comprises receiving the treatment device including the gastric anchor and the gastric electrical stimulator.

30. The method according to claim 29, wherein the gastric electrical stimulator is configured to apply electrical stimulation to the stomach, and to configure the stimulation to generate peristalsis.

31. The method according to claim 29, wherein the gastric electrical stimulator is configured to apply electrical stimulation at between 5 and 7 mA, and at a frequency of between 5 and 40 Hz.

32. The method according to claim 27, wherein the medical treatment device further includes one or more dissolvable elements, and wherein swallowing comprises swallowing the treatment device while the one or more dissolvable elements initially hold the sheet rolled.

33. The method according to claim 32, wherein the one or more dissolvable elements include one or more dissolvable rings, and wherein swallowing comprises swallowing the treatment device while the one or more dissolvable rings are initially placed around the rolled sheet.

34. The method according to claim 32, wherein the one or more dissolvable elements include a dissolvable glue, and wherein swallowing comprises swallowing the treatment device while the dissolvable glue binds an outermost edge of the sheet to a more inner portion of the sheet.

35. The method according to claim 32, wherein the one or more dissolvable elements are selected from the group consisting of:

a dissolvable capsule, and a dissolvable coating, and wherein swallowing comprises swallowing the treatment device while the sheet is within the selected dissolvable element.